Do not give sulfasalazine to infants and children up to 2 years of age, unless otherwise directed by your doctor. It may cause brain problems.

Sulfasalazine is best taken right after meals or with food to lessen stomach upset. If stomach upset continues or is bothersome, check with your doctor.

Each dose of sulfasalazine should also be taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects of the sulfa medicine.

For patients taking the enteric-coated tablet form of this medicine:

• Swallow tablets whole. Do not break or crush.

Keep taking this medicine for the full time of treatment , even if you begin to feel better after a few days. Do not miss any doses.

Dosing

The dose of sulfasalazine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sulfasalazine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking sulfasalazine.

• For prevention or treatment of inflammatory bowel disease:
  • For oral dosage forms (tablets, enteric-coated tablets):
    • Adults and teenagers To start, 500 milligrams (mg) to 1000 mg (1 gram) every six to eight hours. Your doctor may then decrease the dose to 500 mg every six hours. Later, your doctor may change your dose as needed.
    • Children 2 years of age and over Dose is based on body weight and must be determined by your doctor.
      • To start, the dose is usually:
        • 6.7 to 10 mg per kilogram (kg) (3.05 to 4.55 mg per pound) of body weight every four hours or
        • 10 to 15 mg per kg (4.55 to 6.82 mg per pound) of body weight every six hours or
        • 13.3 to 20 mg per kg (6.05 to 9.09 mg per pound) of body weight every eight hours.
      • Then, the dose is usually 7.5 mg per kg (3.41 mg per pound) of body weight every six hours.
    • Infants and children up to 2 years of age Use is not recommended.
  • For rectal dosage form (enema):
    • Adults and teenagers 3 grams (1 unit), used rectally as directed, every night.
    • Children 2 years of age and over Dose must be determined by your doctor.
    • Infants and children up to 2 years of age Use is not recommended.
• For treatment of rheumatoid arthritis:
  • For oral dosage forms (tablets, enteric-coated tablets):
    • Adults and teenagers To start, 500 mg to 1000 mg (1 gram) daily. Your doctor may increase your dose as needed, but the dose is generally not more than 3000 mg (3 grams) a day.
    • For children ages 6 and over 30 to 50 mg per kg of body weight daily, divided into two doses. The medicine is usually started at a lower amount and gradually increased to the actual amount over a month. Typically the amount that is needed does not exceed 2 grams per day. The dose must be determined by your doctor.
    • Infants and children up to 2 years of age Use is not recommended.

Missed dose

If you do miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the enema form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sulfasalazine, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to any of the sulfa medicines, furosemide (e.g., Lasix) or thiazide diuretics (water pills), oral antidiabetics (diabetes medicine you take by mouth), glaucoma medicine you take by mouth (for example, acetazolamide [e.g., Diamox], dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazane]), or salicylates (for example, aspirin). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy Sulfasalazine has not been studied in pregnant women. However, reports on women who took sulfasalazine during pregnancy have not shown that it causes birth defects or other problems. In addition, sulfasalazine has not been shown to cause birth defects in studies in rats and rabbits given doses of up to 6 times the human dose.

Breast-feeding Sulfa medicines pass into the breast milk in small amounts and have been shown to cause unwanted effects in nursing babies with glucose-6-phosphate dehydrogenase (G6PD) deficiency. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children Sulfasalazine should not be used in children up to 2 years of age because it may cause brain problems. However, sulfasalazine has not been shown to cause different side effects or problems in children over the age of 2 years than it does in adults.

Older adults This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sulfasalazine, it is especially important that your health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Ethionamide (e.g., Trecator-SC) or
• Etretinate (e.g., Tegison) or
• Fat emulsions, intravenous (e.g., Intralipid) (with prolonged use) or
• Fluconazole (e.g., Diflucan) or
• Gold salts (medicine for arthritis) or
• Inflammation or pain medicine, except narcotics or
• Iron (with overdose) or
• Labetalol (e.g., Normodyne) or
• Lovastatin (e.g., Mevacor) or
• Mercaptopurine (e.g., Purinethol) or
• Methimazole (e.g., Tapazole) or
• Naltrexone (e.g., ReVia) (with long-term, high-dose use) or
• Niacin (with high doses, sustained release, and antihyperlipidemic use) or
• Nitrofurans or
• Other anti-infectives by mouth or by injection (medicine for infection) or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Plicamycin (e.g., Mithracin) or
• Pravastatin (e.g., Pravachol) or
• Propylthiouracil (e.g., Propyl-Thyracil) or
• Simvastatin (e.g., Zocor) or
• Troleandomycin or
• Valproic acid (e.g., Depakene) or
• Vitamin A (with chronic overdose) Use of sulfasalazine with these medicines may increase the chance of side effects affecting the liver

• Acetohydroxamic acid (e.g., Lithostat) or
• Dapsone or
• Furazolidone (e.g., Furoxone) or
• Menadiol (e.g., Synkavite) or
• Nitrofurantoin (e.g., Furadantin) or
• Primaquine or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Quinine (e.g., Quinamm) or
• Sulfoxone (e.g., Diasone) Use of sulfasalazine with these medicines may increase the chance of side effects affecting the blood

• Anticoagulants (blood thinners) or
• Ethotoin (e.g., Peganone) or
• Mephenytoin (e.g., Mesantoin) Use of sulfasalazine with these medicines may increase the chance of side effects of these medicines

• Antidiabetics, oral (diabetes medicine you take by mouth) Use of oral antidiabetics with sulfasalazine may increase the chance of side effects affecting the blood and/or increase the side effects of oral antidiabetics

• Methotrexate (e.g., Mexate) Use of methotrexate with sulfasalazine may increase the chance of side effects affecting the liver and/or increase the side effects of methotrexate

• Methyldopa (e.g., Aldomet) Use of methyldopa with sulfasalazine may increase the chance of side effects affecting the liver and/or the blood

• Phenytoin (e.g., Dilantin) Use of phenytoin with sulfasalazine may increase the chance of side effects affecting the liver and/or increase the side effects of phenytoin

• Allergies, severe or
• Asthma, bronchial The risk of an allergic reaction to sulfasalazine may be increased
• Blood problems or
• Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme) Patients with these problems may have an increase in side effects affecting the blood

• Intestinal blockage Sulfasalazine will not reach the site of action in the bowel

• Kidney disease or
• Liver disease Patients with kidney disease or liver disease may have an increased chance of side effects

• Porphyria Use of sulfasalazine may cause an attack of porphyria

• Urinary blockage Sulfasalazine may not be eliminated properly, causing an increased risk of side effects